Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amended claim set filed 9/15/2025 is acknowledged.
Claims 1, and 2 are withdrawn.
Claims 3-20 will be examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 9/15/2025 is acknowledged.
Claims 1 and 2 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/2025.
Specification
The use of the term BPL1® at least on page 4 of the specification, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Biological Deposits
Claims 9, 10, and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed biological materials are: (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809. The specification lacks complete deposit information for the Lactobacillus plantarum DR7 and Bifidobacterium lactis 1 BLP1® cells. Because it is not clear that the cells possessing the properties of the aforementioned cells are known and publicly available or can be reproducibly isolated without undue experimentation, and because the invention of claims 9, 10, and 12 claims or uses the aforementioned cells, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the aforementioned cells is necessary to practice the instant invention or filing of evidence of deposit is required. Without a publicly available deposit of the aforementioned cells, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the aforementioned cells is an unpredictable event. Applicants must comply with the criteria set forth in 37 CFR 1.801-1.809.
If the deposits are made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the aforementioned cells have been deposited under the Budapest Treaty, that the aforementioned cells will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that the aforementioned cells will be replaced should they ever become non-viable, would satisfy the deposit requirement made herein.
If the deposits have not been made under the Budapest Treaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number.
For each deposit made pursuant to these regulations, the specification shall contain:
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
The name and address of the depository;
The name and address of the depositor;
The date of deposit;
The identity of the deposit and the accession number given by the depository; (5) The date of the viability test;
The procedures used to obtain a sample if the test is not done by the depository; and
A statement that the deposit is capable of reproduction.
Applicant must assure that:
Access to the deposit will be available during pendency of the patent application making reference to the deposit.
All restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
In the instant application, at least the following issues exist. Searching Google for the Lactobacillus plantarum DR7 and Bifidobacterium lactis 1 BLP1® cells did not uncover readily available sources.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the Applicant’s possession at the time the application was filed.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit along with the necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC 1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “postbiotic” in claim 3 is used by the claim to mean “living bacteria,” while the accepted meaning is “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host” as evidenced by Salminen et al. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotic, Nature Reviews | Gastroenterology & Hepatology, volume 18, September 2021 page 649, abstract. The term is indefinite because the specification does not clearly redefine the term to include live bacteria in contrast to the accepted meaning. However, the specification and claims infer that the bacteria can still be alive insofar as they can metabolize carbon sources; see paragraph [0042] and claim 3.
Claim 4 recites the limitation "the method of claim 1" in the preamble. There is insufficient antecedent basis for this limitation in the claim because claim 1 is withdrawn. Claims 5-20 depend upon claim 4 and do not resolve the ambiguity.
Claims 6-8 recite two instances of the same ingredient separated by an “and” this is indefinite you can only have 1 amount of a specific ingredient in a single composition. As an example, claim 6 recites “nutritional supplement comprises 80 and 120 milligrams of the prebiotic” it is unclear if this means the supplement has 80, or 120 or 200 milligrams of the prebiotic. The examiner proposes this rejection may be overcome by writing “nutritional supplement comprises between 80 and 120 milligrams of the prebiotic” and support for this is found in paragraph [0023] of the specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Physicians choice Thin 30 Probiotic Supplement which is supported by these 3 screens captures in PTO-892. (Thin30r1 ingredients Physician's Choice _ Thin 30 Probiotic Supplement.pdf) hereinafter Thin30r1, (Thin30r2 Thin 30 Probiotic for Weight Loss Support - 30 Capsules _ Physician_s Choice.pdf) hereinafter Thin30r2. This product was released before 2/17/2020 as evidenced by (Thin30r3 Evidence of age Physician's Choice Thin 30 Probiotic Delayed-Release Capsules, 30 CT - CVS Pharmacy.pdf) page 5 screen capture taken 2/17/2026.
Claim 3 of the instant application teaches “A method to promote weight loss in a human subject, comprising administering an effective amount of a nutritional supplement to the human subject, wherein the effective amount of the nutritional supplement is effective to cause weight loss in the human subject”, Thin30r1 page 1 teaches a nutritional supplement and recites “Support weight management” and “Lose 30 lbs. in 90 days” The instant application teaches the nutritional supplement comprising “a probiotic bacterium; a postbiotic bacterium;” in claim 3, Thin30r2 page 3 teaches a ingredients including Lactiplantibacillus plantarum and Bifidobacterium lactis which are the claimed probiotic and postbiotic respectively of the instant application. In claim 3 the instant application teaches “a phytobiotic” Thin30r2 teaches a phytobiotic in the form of green tree complex which is an inherent property of green tree as evidenced by Kaurachi et al. (Matcha Tea Powder’s Antidepressant-like Effect through the Activation of the Dopaminergic System in Mice Is Dependent on Social Isolation Stress, Nutrients 2023, 15, 581.). Claim 3 of the instant application teaches “a prebiotic comprising fiber that the probiotic and/or postbiotic bacterium can metabolize as a carbon source.” And the specification teaches such a prebiotic to be acacia gum from acacia trees in paragraph [0019]. Thin30r2 page 3 teaches a prebiotic blend of 150 mg which contains organic acacia fiber as the first ingredient and thus equal to or greater in amount than the other prebiotic ingredients.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
In the interest of compact prosecution, the examiner has written 103 rejections as if the applicants intended claim 4 to be dependent on claim 3, see 112(b) rejection of claim 4 above, and claims 6-8 as the examiner proposed amendment above.
Claims 3,4, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Biowish Technologies (U.S. Patent Pub. US20170304377A1; Publication date 10/26/2017) hereinafter Biowish, in view of Chundakkattumalayil et al. (Role of L. plantarum KX519413 as Probiotic and Acacia Gum as Prebiotic in Gastrointestinal Tract Strengthening) hereinafter Chundakkattumalayil, in further view of Dushenkov et al. (U.S. Patent Pub. US 20070088078 A1; Publication date 4/19/2007) hereinafter Dushenkov .
Claim 3 of the instant application is drawn to a method to promote weight loss in a human subject, Biowish teaches a nutritional supplement which reduces weight and recites “Overall, there was a significant effect on both weight loss and/or waist reduction following 12 weeks of ingestion of the product. Subjects lost and average of 2.4 kg over 12 weeks of the test” in paragraph [0110]. In the interest of compact prosecution, the rest of claim 3s elements will be addressed in the rejection of claim 4 as they will read back on claim 3.
Claim 4 of the instant application is drawn to a probiotic bacterium is Lactobacillus plantarum, Biowish teaches probiotics as “The Lactobacillus microorganisms include for example Pediococcus acidilactici, Pediococcus pentosaceus, Lactobacillus plantarum.” In paragraph [0009].
The instant application teaches “the prebiotic is acacia gum” Biowish teaches a botanical in paragraph [0077] Acacia catechu which is either a similar species of tree or the same species as acacia gum. In the event it is a different product, it would have been obvious to one of skill in the art to use acacia gum as the prebiotic because it has been shown to improve gastrointestinal track colonization in conjunction with L. plantarum in Figure 3 of Chundakkattumalayil.
The instant application teaches the phytobiotic is orange peel extract. Biowish does not teach orange peel extract in the specific oral embodiment. However, Biowish does teach orange peel extract in a skincare cream in paragraph [0153] indicating it is acceptable for use with the probiotics. It would have been obvious to use the orange peel extract in the nutritional supplement because it is used for weight loss as taught by as taught by Dushenkov in claim 1.
The instant application teaches the “postbiotic bacterium is Bifidobacterium lactis”, Biowish teaches the post biotic is optionally Bifidobacterium animalis in paragraph [0012]. Bifidobacterium lactis is a subspecies of animalis.
Claim 13 of the instant application is drawn to a variety of suitable dosage forms, including, without limitation, tablets, capsules, granules. Biowish teaches these dosage forms in paragraph [0018].
Claim 7 of the instant application teaches between 100 and 150 milligrams of the phytobiotic, Dushenkov teaches orange peel extract in paragraph [0020] and further teaches typically about 100 mg and about 200 mg in paragraph [0023]. One of skill in the art would have been motivated to optimize the amount to minimize size and costs and it would not be undue experimentation to try the listed amounts in Dushenkov.
Claim 15 of the instant application teaches “and the final weight no more than 98 percent of the initial weight.” This is inherent to the weight loss method of claim 4.
Claim 16 of the instant application is drawn to administering the nutritional supplement to the human subject once or twice daily for at least 4 weeks, Biowish teaches administration of the supplement for 12 weeks twice a day.
See MPEP 2112. For claims 17-19, the nutritional supplement comprises the orange peel extract, and claims 17-19 do not further limit the product containing orange peel extract. The intended use does not limit the claim unless it results in a structural difference in the product (see MPEP 2111.02).
Claim 17 of the instant application teaches phytobiotic in an amount that is effective to inhibit stress in the human subject, this is inherent to the properties of the orange peel extract as evidenced in the specification paragraph [0020]
Claim 18 of the instant application teaches phytobiotic in an amount that is effective to improve sleep quality in the human subject, paragraph [0020] of the specification teaches orange peel extract reduces stress and this will inherently improve sleep quality as evidenced by Kalmback et al. (The impact of stress on sleep: Pathogenic sleep reactivity as a vulnerability to insomnia and circadian disorders J Sleep Res. 2018 December; 27(6): e12710. doi:10.1111/jsr.12710.) hereinafter Kalmback, Page 2 introduction.
Claim 19 of the instant application teaches phytobiotic in an amount that is effective to modulate dopamine in the human subject, this is inherent to the properties of the orange peel extract as evidenced in the specification paragraph [0020]
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Biowish in view of Chundakkattumalayil in further view of Dushenkov, in further view of Thin30r2.
Biowish teaches “When formulated for oral administration the compositions comprise at least 0.1, 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or more w/w % of the pre-, pro- and post probiotic mixture.” In paragraph [0068] and also teaches “in yet another preferred embodiment the compositions of the invention are formulated into a capsule containing only the Microbiotic Composites™ in concentrations ranging from 5-500 mg” These concentrations would have provided obvious starting points for routing optimizations of the probiotic range of 20-70mg in claim 5.
Claim 5 of the instant application teaches 20 to 70 milligrams of the probiotic bacterium, Thin30r2 page 3 teaches a probiotic blend of 45 milligrams. It would have been obvious to use an existing known effective number of probiotics for weight loss as a starting point when selecting from the options taught by Biowish.
Claim 6 of the instant application teaches between 80 and 120 milligrams of the prebiotic. Thin30r2 page 3 teaches 150 mg of prebiotic blend. One of ordinary skill in the art would have been motivated to optimize this to lower the amount to save costs and since the orange peel extract of the phytobiotic also contains fiber it would not affect efficacy of the prebiotic capabilities of the composition.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Biowish in view of Chundakkattumalayil in further view of Dushenkov, in further view of Pedret et al. (Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial, International Journal of Obesity (2019) 43:1863–1868) hereinafter Pedret.
Claim 8 of the instant application is drawn to between 10 and 50 milligrams of the postbiotic. Pedret teaches the use of 100mg of L. lactis BPL1® in methods of page 1864. Since the instant application already uses a probiotic with about 50 mg, it would have been obvious to one of skill in the art to reduce the amount of postbiotic to save costs and still retain the weight loss outcomes.
Claim 10 of the instant application teaches the postbiotic is heat-treated Bifidobacterium lactis 1 ("HT BPL1®"), Pedret also teaches the use of HT BPL1® which is referred to as h-k Ba8145, and shows it is still effective for weight loss as is live B. Lactis BPL1® in the conclusions on page 1863. One of skill in the art would have been motived to use a heat killed postbiotic because it is more stable during long term storage and transportation as it does not need to remain viable. Improved logistical flexibility will also reduce costs and increase shelf life.
Claim 20 of the instant application is drawn to a postbiotic in an amount that is effective to cause weight loss in the human subject. Pedret teaches the use of 100mg of L. lactis BPL1® in methods of page 1864. It would have been obvious to combine the known use of the postbiotic with the known concentrations to yield a predictable result of an effective amount to cause weight loss.
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable Biowish in view of Chundakkattumalayil in further view of Dushenkov, in further view of Lui et al (Lactobacillus plantarum DR7 Modulated Bowel Movement and Gut Microbiota Associated with Dopamine and Serotonin Pathways in Stressed Adults, Int. Journal of mol. sciences Published: 29 June 2020) hereinafter Lui
Claim 9 of the instant application is drawn to the probiotic is Lactobacillus plantarum DR7, Lui teaches a specific strain of L. plantarum DR7 which alleviates stress and anxiety in stressed adults and improved memory and cognition, inflammatory markers where also reduced on page 2. It would have been obvious to one skilled in the art to select a strain of L. plantarum with the multitude of listed health advantages above as a probiotic.
Claim 14 of the instant application is drawn to a probiotic bacterium in an amount that is effective to inhibit inflammation, the teachings of Lui are recited above and it would have been obvious to select a probiotic strain such as L. plantarum DR7 and use an effective amount to reduce inflammation.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Biowish in view of Chundakkattumalayil in further view of Dushenkov, in further view of Heuer et al. (U.S. Patent Pub. US 20150201661 A1; Publication date 7/23/2015)
Claim 11 of the instant application is drawn a nutritional supplement of claim 4 further comprising bamboo leaf extract. The reasons why claim 4 is rendered obvious by Biowish in view of Chundakkattumalayil and Dushenkov are set forth above, however none of these references teaches including one of the additional elements recited in claim 11.
Heuer teaches a composition for reducing the body weight of an animal in paragraph [0001], which may be a human, see paragraph [0072] and in claim 23. And further teaches “In a preferred embodiment, the bamboo extract of this invention is a natural extract from the leaves of Phyllostachys Sieb” in paragraph [0044]. A person having ordinary skill in the art would have been motivated to combine the bamboo leaf extract to add more weight loss ingredients to the mixture for synergistic effects as well as the added benefits of high silica for maintaining the integrity and health of the skin, ligaments, tendons and bones.
Claim 12 of the instant application teaches comprises about 50 milligrams of Lactobacillus plantarum DR7 the probiotic; see rejection for claim 5.
about 100 milligrams of acacia gum the prebiotic; see rejection for claim 6
about 125 milligrams of orange peel extract, the phytobiotic; see US 20070088078 A1
and about 34 milligrams of Bifidobacterium lactis 1 ("BPL1®") the post biotic. See rejection for claim 8
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable Biowish in view of Chundakkattumalayil in further view of Dushenkov, in further view Larson et al. (Acacia Gum Is Well Tolerated While Increasing Satiety and Lowering Peak Blood Glucose Response in Healthy Human Subjects, Nutrients 2021, 13, 618) hereinafter Larson.
Claim 13 of the instant application is drawn to a prebiotic in an amount that is effective to inhibit appetite. Larson teaches acacia gum inhibits appetite in the conclusion on page 11 and table 3. It would have been obvious to combine the amounts taught by Larson with the prebiotic of the instant claims to suppress appetite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18729156 (NUTRITIONAL SUPPLEMENTS AND METHODS OF NUTRITIONAL SUPPLEMENTATION AFFECTING WEIGHT LOSS) hereinafter app156. Although the claims at issue are not identical, they are not patentably distinct from each other because app156 claims a composition and the claims recite that it can be used to decrease weight, the claims do not actually recite a method of administering. Nevertheless, upon reading claims 1-15 of app156 a person having ordinary skill in the art would immediately envision administering, thereby arriving at the invention of instant claims 3-20.
App156 claims 3-12 teach the compositions for use in the methods of instant claims 3-12 respectively. Instant claim 15 is inherent to the weight loss method of claim 4 which is rejected above. App156 claim 15 teaches oral administration at a rate of once or twice a day over 4 weeks as claimed by instant claim 16.
Claim 17 of the instant application teaches a phytobiotic in an amount that is effective to inhibit stress. App156 does not teach this in the claims however App156 paragraph [0020] of the specification teaches in the exemplary embodiment, a phytobiotic which reduces the feeling of stress.
Claim 18 of the instant application teaches a phytobiotic in an amount that is effective to improve sleep quality in the human subject, app156 paragraph [0020] of the specification teaches the phytobiotic orange peel extract reduces stress and this will inherently improve sleep quality as evidenced by Kalmback page 2 introduction. A person having ordinary skill in the art would be motivated to use a photobiotic which reduces stress and thus would inherently improve sleep quality.
Claim 19 of the instant application teaches a phytobiotic in an amount that is effective to modulate dopamine in the human subject, this is inherent to the properties of the orange peel extract which is used may be used a phytobiotic as evidenced in the specification of app156 paragraph [0020]. A person having ordinary skill in the art would be motivated to use a photobiotic which reduces stress as an added advantage on top of weight loss.
Claim 20 of the instant application is drawn to a postbiotic in an amount that is effective to cause weight loss in the human subject. App156 teaches a postbiotic configured to increase weight loss in paragraph [0007].
App156 claim 13 teaches the nutritional supplement for inhibiting appetite but does not specify the component that provides this feature must be the prebiotic as in instant claim 13. Larson teaches acacia gum inhibits appetite in the conclusion on page 11 and table 3. It would have been obvious to a person having ordinary skill in the art to combine use the acacia gum taught by Larson as the prebiotic of the instant claim 13 to suppress appetite as that would synergize with weight loss in a weight loss product.
App156 claim 14 teaches the nutritional supplement for inhibiting inflammation but does not specify the component that provides this feature must be the probiotic as in instant claim 13. Lui teaches a L. plantarum DR7 which alleviates stress and anxiety in stressed adults and improved memory and cognition, inflammatory markers where also reduced on page 2. It would have been obvious to one skilled in the art to select the strain of L. plantarum DR7, which is a probiotic, with the multitude of added health advantages above as the component to reduce inflammation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645